Peripheral Artery Disease Clinical Trial
Official title:
A Phase IV Multicenter Study of Iomeron®-400 Used With Multi-detector Computed Tomography Angiography (MDCTA) of the Thoraco-Abdominal Aorta, and the Carotid, Pulmonary, and Peripheral Arteries
This is a Phase IV multicenter, open-label study and is being implemented in order to assess diagnostic image quality of MDCTA in subjects undergoing computed tomography angiography (CTA) of the thoraco-abdominal aorta, and the carotid, pulmonary and peripheral arteries with IOMERON.
This is a Phase IV multicenter, open-label study and is being implemented in order to assess
diagnostic image quality of MDCTA in subjects undergoing computed tomography angiography
(CTA) of the thoraco-abdominal aorta, and the carotid, pulmonary and peripheral arteries
with IOMERON. The hypothesis is that IOMERON used at a high concentration will provide good
diagnostic image quality. The Investigators will also function as readers and evaluate the
images on-site. Efficacy analysis will be based on the on-site evaluations.
Imaging conditions will be representative of those used in routine clinical practice. The
study will be conducted at approximately 10-20 sites in China. Each site may enroll
approximately 40 subjects in this study. Approximately 400 subjects will be enrolled in
order to obtain 360 evaluable subjects who undergo elective MDCTA of the thoraco-abdominal
aorta, or carotid, pulmonary or peripheral arteries.
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